摘要
本研究借鉴多负荷铜IUD的外形，利用国产TCu200CIUD的材料，进行改进，研制出FRCu200IUD。经基础研究，对材料和消毒的安全性进行了验证。经三期临床研究，结果显示FRCu200CIUD的续用率为96．13／100妇女年，妊娠率0．46／100妇女年，脱落率1．47／100妇女年，因出血／疼痛取出率1．57／100妇女年。FRCU20CIUD保留了多负荷铜IUD设计上的优点，并将钢丝改为铜套，且价格低廉，符合我国国情，为育龄妇女提供了一种新型活性IUD。
A new IUD,FRCu200C was designed by using the material of frame of TCu220C. The shape is like MLCu375,not cupper wire but four cupper pipes,total cupper surface area 200mm2. A clin-ical trial was carried out in 30 cases of FRCu200C in I stage clinical trial and showed a good situa-tion. Followed this,a comparative randomized clinical trial was done between FRCu200C and ML-Cu375 in 120 cases respectively in Ⅱ stage clinical trial. Life table analysis was made according Tieze and Pottef and no diHerence between the two IUDs in pregnancy rate, expulsion rate,re-moval rate due to bleed/pain. A multicentre clinical Ⅲ stage trial was done in 5 centres,total 1085 cases in one year and we found that the pregnancy rate at the end of 12 months was 0. 46%,the expulsion rate was 1. 47 %,removal rate due to bleed/pain was 1. 57%,the continuation rate was 96. 13 %. It showed that the continuation rate was high and pregnancy,expulsion and removal due to bleed/pain were low. The FRCu200C rnay become an ideal device for fertile women.
出处
《生殖与避孕》
CAS
CSCD
北大核心
1997年第1期23-27,共5页
Reproduction and Contraception
